IVDR performance report medical devices|IVD clinical evidence report

1. Why the IVD performance evaluation is so important? Summary To know the importance of IVD performance evaluation, it is really necessary to know the consequences that will be following a poorly conducted performance evaluation. If you are an IVD manufacturer then it is highly suggested that you do not commit them. a) In vitro diagnostic medical devices IVDs are used in discerning information using samples from humans like tissue and blood. These helping in knowing about the pathological and physiological changes that the body is going through. What an IVD can identify? In blood: it detects tumour markers In a smear: it can detect Coronavirus (SARS-CoV-2) In a biopsy: it can detect cancer cells Such information forms the guidelines for diagnosis and aids in the future treatments of a patient. So it is crucial that the information is absolutely correct as this will ensure whether the patient receives the intended clinical benefits or not. b) Areas of IVD errors It is highly probable that the results derived through IVD might be incorrect in several situations: Considered Incorrect: False Positive: When some abnormality is detected by the IVD in the test result even when the patient is not showing any symptoms. False Negative: When the IVD fails to detect any illness despite the patient having all symptoms or being ill. IVD giving inaccurate results. Complete absence of information or delay in the detection and display of results.

2. List of reasons for such similar errors: Unsuitable analysis procedure Manufacturer’s failure to track each factor that might impact the tissue sample like drugs effect. Change in reagents due to heat light or air. Patient data getting mixed up due to software malfunction. Cross-contamination of samples might be occurring due to the slightest mismanagement. c) Effect on Patients The consequences of wrong information are extreme for patients. False-positive results are quite nerve wracking and lead to unwanted stress like: Too many blood tests Needles biopsies Unnecessary therapies, operations, and medications False-negative can in turn lead to delays in conducting the procedures that would have been needed immediately thus affecting public health. d) Effects on Manufacturers When an IVD functions properly, it ensures both patient safety as well as safety for the manufacturing company as they do not need to face extreme consequences. If the device fails to work as plan its release in the market is delayed and the company has to encounter loss of sales. Withdrawing the faulty IVD from the market harms the reputation of the company as product recalls need to be published in the authority sites by the manufacturers. If any patient has been harmed by the IVD then the company might even have to pay compensation for the same. Apart from the previously mentioned losses, the company has to bear additional costs to be used for the purpose of product improvement. MakroCare with a global team of 90+ Clinicians, Diagnostic technologists, Micro Biology associates, Writers, and Scientific experts can help you achieve your Performance Evaluation goals, on time with scalable competitive cost models (unit, hourly, fte) Want more information? Get in touch with us. Ask our Experts www.makrocare.com Copyright © 2020 MakroCare LLC. All rights reserved.